MAUDE Adverse Event Report: BRIVANT LIMITED HI-TORQUE CONNECT,4G,300

Model Number	901022-03
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the 90% stenosed, heavily tortuous popliteal artery.When advancing the connect 18 guide wire to the lower limb arteries, resistance was noted, and the tip of the guide separated in the guide catheter.Resistance was noted during removal, so the guide wire and guide catheter were removed, with force, together, as a single unit.There was no reported adverse patient effect and no clinically significant delay in the procedure.Another connect 18 was used to continue the procedure.No additional information was provided.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the 90% stenosed, heavily tortuous popliteal artery.When advancing the connect 18 guide wire to the lower limb arteries, resistance was noted, and the tip of the guide separated in the guide catheter.Resistance was noted during removal, so the guide wire and guide catheter were removed, with force, together, as a single unit.There was no reported adverse patient effect and no clinically significant delay in the procedure.Another connect 18 was used to continue the procedure.No additional information was provided.

• Brand Name: HI-TORQUE CONNECT,4G,300
• Common Device Name: HI-TORQUE CONNECT,4G,300
• Manufacturer (Section D): BRIVANT LIMITED; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): BRIVANT LIMITED; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 15291612
• Report Number: 3006010712-2022-00034
• Device Sequence Number: 12589459
• Product Code: DQX
• UDI-Device Identifier: 08717648174995
• UDI-Public: 08717648174995
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 901022-03
• Device Catalogue Number: 1012589
• Device Lot Number: 6600371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown